NLDataProtection object

Legal framework (on safeguarding the collection, handling, recording, keeping and/or processing of any clinical trial related data and patient files)

National Data Protection Act
Implementing Decrees and Ordinances
Other legislation covering DP related issues

National DP act

(1) Personal Data Act: SFS 1998:204

(2) Patient Data Act (Patientdatalag, SFS 2008:355).
The Act provides coherent regulation of the processing of personal data in the healthcare sector (how medical records must be kept for all patient care and how the information may be used by the health care providers’ staff). The purpose of the legislation is to ensure increased patient security and protection of patients' privacy.

Implementing decrees / ordinances

Personal Data Ordinance: SFS 1998:1191

Additional Information

Handling of personal data must comply with the applicable Swedish Data Protection Acts and Ordinances (pursuant to Chapter 3 (3) LVFS 2003:6).

The unofficial English versions of the above mentioned Acts and Ordinances are provided on the Datainspektionen website in section Legislation.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395